Senior Clinical Research Director (AI)

Location: Cambridge, Massachusetts, United States; hybrid role. Applicants must be US or Puerto Rico residents.

Salary: $236,250–$393,750 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, AI, data, and digital platforms.

What you will do

• Lead clinical development plans, integrated development plans, and clinical strategy for assigned programs.
• Provide medical leadership for clinical studies and registries, including protocols, clinical study reports, key results, and study documents.
• Oversee clinical trial execution, feasibility, timelines, budgets, risk management, data review, and compliance with GCP, laws, regulations, and SOPs.
• Lead study committees and coordinate with clinical operations, biostatistics, pharmacovigilance, regulatory, investigators, and other stakeholders.
• Represent projects in regulatory agency meetings and lead clinical sections of BLA/CTD, IND, CTA, DSUR, RMP, PSP/PIP, and related submissions.
• Evaluate scientific data, contribute to manuscripts and abstracts, support advisory boards, and mentor CRDs and Clinical Scientists.

Requirements

• Medical Doctor degree or equivalent.
• At least 5 years of clinical development experience in the pharmaceutical industry or a CRO.
• Strong scientific and clinical expertise, including clinical study methodology and life cycle management.
• Excellent written and spoken English; strong communication, teaching, negotiation, and risk-management skills.
• Ability to work in a matrix organization and collaborate across international and intercultural teams.
• Must be a US or Puerto Rico resident for this position.

Nice to have

• MD/PhD.
• Specialization in hematology.
• Experience applying new digital solutions in clinical development.

Culture & Benefits

• Supportive, future-focused environment centered on scientific innovation and patient-informed drug development.
• Career growth opportunities through promotion or lateral moves, including international opportunities.
• Employee rewards and benefits package with healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Work with AI, data, and digital platforms to advance drug discovery and clinical research.